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Sign in to claim this brandRoche Diagnostics Corp.
US
Last updated May 23, 2026
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Catalogue (1711)
Page 2 of 35| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| cobas® WNV Control Kit | 07001118190 | FDA UDI | N/A | Active |
| PreciControl Rubella IgM | 4618840190 | FDA UDI | Class I | Active |
| alpha-Amylase liquid acc. to IFCC | 11876473316 | FDA UDI | Class II | Unknown |
| Bilirubin Total Gen3 | 5795397190 | FDA UDI | Class II | Active |
| Total Protein Gen2 | 5171385190 | FDA UDI | Class II | Active |
| free PSA CalSet | 08851964190 | FDA UDI | Class III | Active |
| cobas b 123 Fluid Pack 400 | 5403154001 | FDA UDI | Class II | Unknown |
| Elecsys Vitamin B12 II | 07028121190 | FDA UDI | Class II | Active |
| Tina-quant CReactive Protein IV | 07876424190 | FDA UDI | Class II | Active |
| Elecsys AntiCCP Immunoassay | 5031656160 | FDA UDI | Class II | Active |
| Methaqualone | 20753610122 | FDA UDI | Class II | Active |
| Bilirubin Total Gen.3 | 08056960190 | FDA UDI | Class II | Active |
| Elecsys Progesterone III CalCheck 5 | 7092555190 | FDA UDI | Class I | Active |
| NAcetylProcainamide | 20737852322 | FDA UDI | Class II | Active |
| Magnesium Gen.2 | 08058016190 | FDA UDI | Class I | Active |
| AFP CalCheck | 11776614190 | FDA UDI | Class I | Active |
| Homocysteine Enzymatic Assay | 08057826190 | FDA UDI | Class II | Active |
| Fructosamine | 11930010216 | FDA UDI | Class II | Unknown |
| Factor II Prothrombin G20210A Kit | 1 | FDA UDI | Class II | Active |
| Acetaminophen | 20767174160 | FDA UDI | Class II | Unknown |
| Elecsys HCG+beta | 07251025190 | FDA UDI | Class II | Active |
| PreciControl HE4 | 5950953190 | FDA UDI | Class I | Active |
| Calcium Gen2 | 5168449190 | FDA UDI | Class II | Active |
| Urisys 2400 Cassette | 3012557061 | FDA UDI | Class II | Active |
| Cfas CKMB | 11447394216 | FDA UDI | Class II | Active |
| CalSet beta-Amyloid (1-42) II | 08821976190 | FDA UDI | Class II | Active |
| Elecsys HE4 | 07027478190 | FDA UDI | Class II | Active |
| Preciset Serum proteins | 11876406216 | FDA UDI | Class II | Unknown |
| Phenytoin | 5108411190 | FDA UDI | Class II | Active |
| Elecsys DHEA-S | 07027192190 | FDA UDI | Class I | Active |
| Calcium Gen2 | 5061482190 | FDA UDI | Class II | Active |
| Elecsys sFlT-1 | 09015353160 | FDA UDI | Class II | Active |
| Elecsys IgE CalCheck 5 | 5918022160 | FDA UDI | Class I | Active |
| ISE indirect Na K Cl for Gen.2 | 4522320190 | FDA UDI | Class II | Active |
| Barbiturates Plus | 4499018190 | FDA UDI | Class II | Active |
| PreciControl AMH | 06709966190 | FDA UDI | Class I | Active |
| Elecsys SHBG CalCheck 5 | 6269915160 | FDA UDI | Class I | Active |
| Direct Bilirubin | 12217716001 | FDA UDI | Class II | Unknown |
| Potassium Electrode | 21029355001 | FDA UDI | Class II | Active |
| Tinaquant RF II | 3004953122 | FDA UDI | Class II | Active |
| Elecsys Anti-HBe | 07026838190 | FDA UDI | Class II | Active |
| Elecsys Prolactin II | 07027737190 | FDA UDI | Class I | Active |
| Elecsys TSH Assay | 11731459122 | FDA UDI | Class II | Active |
| cobas pro Sample Buffer | 08463689001 | FDA UDI | Class I | Active |
| Elecsys HSV1 IgG Immunoassay | 5572185160 | FDA UDI | Class II | Active |
| sTfR Control Set | 12148340122 | FDA UDI | Class II | Active |
| Elecsys HSV-2 IgG | 08948887160 | FDA UDI | Class II | Active |
| Aspartate Aminotransferase acc to IFCC without pyridoxal phosphate activation | 20764949322 | FDA UDI | Class II | Active |
| Alanine Aminotransferase / Aspartate Aminotransferase acc. to IFCC with PYP | 5531462190 | FDA UDI | Class I | Active |
| Precimat Fructosamine | 11098993122 | FDA UDI | Class II | Active |
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